Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Remote Exercise Program for Pediatric ICU Survivors

28 de julio de 2026 actualizado por: Sung Eun Hyun, Seoul National University Hospital

Feasibility Study of a Remote Exercise Intervention Program for Preventing Post-Intensive Care Syndrome in Pediatric Critical Illness Survivors

This pilot clinical trial aims to evaluate the feasibility and safety of a remote exercise intervention program designed to prevent pediatric post-intensive care syndrome (PICS-p) in children discharged from the pediatric intensive care unit (PICU). Children aged 3 to 18 years who received intensive care for at least 48 hours and have not recovered to their pre-admission functional status will participate in an individualized home-based exercise program for 12 weeks. The intervention includes remotely supervised exercise sessions, prescribed self-exercise, and weekly monitoring using videoconferencing. Study assessments will be performed at baseline, immediately before intervention initiation, monthly during the 12-week intervention, and 1 month after completion of the intervention to evaluate feasibility, safety, functional recovery, and maintenance of treatment effects.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Pediatric survivors of critical illness are at risk of developing pediatric post-intensive care syndrome (PICS-p), which includes physical, cognitive, emotional, and social impairments that may persist after discharge from the pediatric intensive care unit (PICU). Although early rehabilitation is recognized as an important strategy for improving recovery, sustained rehabilitation after hospital discharge remains challenging because of barriers such as repeated hospital visits and limited accessibility.

The purpose of this single-arm pilot clinical trial is to evaluate the feasibility and safety of a remote exercise intervention program for children at risk of PICS-p after PICU discharge and to generate preliminary data for a future confirmatory clinical trial.

Eligible participants are children aged 3 to 18 years who received treatment in the PICU for at least 48 hours and have not recovered to their pre-admission functional status. Participants will receive an individualized home-based exercise program consisting of remotely supervised exercise sessions, prescribed self-exercise using instructional video content, and weekly monitoring and feedback through videoconferencing.

The intervention will be delivered over 12 weeks. Outcome assessments will be conducted after PICU discharge (baseline), immediately before intervention initiation, monthly during the intervention, and 1 month after completion of the intervention to evaluate maintenance of treatment effects.

The primary outcomes include feasibility and safety, including adherence, completion rate, user satisfaction, adverse events, and reasons for discontinuation. Secondary outcomes include exploratory changes in physical function, respiratory function, balance, gait speed, muscle strength, motor performance, physical activity, activities of daily living, disability, quality of life, anxiety, and depressive symptoms. The findings will be used to optimize the intervention protocol and support the design of a future confirmatory clinical trial.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

10

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Seung Ha Lee, M.S.
  • Número de teléfono: +82-2-2072-3608
  • Correo electrónico: pedshlee@gmail.com

Ubicaciones de estudio

  • Corea del Sur
      • Seoul, Corea del Sur, 03080
        • Seoul National University Hospital
        • Contacto:
          • Seung Ha Lee, M.S.
          • Número de teléfono: +82-2-2072-3608
          • Correo electrónico: pedshlee@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age 3 to 18 years.
  • Discharged from the pediatric intensive care unit (PICU) after at least 48 hours of treatment.
  • Has not recovered to the pre-PICU level of physical function (walking and mobility), confirmed using the Pediatric Overall Performance Category Scale (POPC) and the Gross Motor Function Classification System Family Report Questionnaire (GMFCS Family Report).
  • Has sufficient cognitive and physical ability to understand and participate in the home-based exercise intervention.
  • Able to maintain adequate attention for exercise training, assessed using the Richmond Agitation-Sedation Scale (RASS) and age-appropriate delirium assessment (psCAM-ICU or pCAM-ICU), when applicable.
  • Written informed consent provided by the parent or legal guardian.

Exclusion Criteria:

  • Newly developed neuromuscular disease after PICU admission that prevents participation in the video-based exercise program without therapist assistance.
  • Medical conditions, indwelling catheters, or implanted medical devices requiring restriction of limb movement.
  • Language or cognitive impairment that prevents understanding of the video-based exercise program.
  • Uncontrolled hypertension, arrhythmia, persistent fever due to infection, or any condition making exercise unsafe.
  • Declines to participate in the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Remote Exercise Intervention
Participants will receive an individualized home-based remote exercise intervention program for 12 weeks following discharge from the pediatric intensive care unit. The intervention includes individualized exercise prescription, instructional exercise videos, prescribed self-exercise, and weekly monitoring and feedback through videoconferencing.
Conductual: Remote Exercise Intervention Program
Participants will receive an individualized home-based remote exercise intervention program for 12 weeks. The intervention consists of individualized exercise prescription, instructional exercise videos, prescribed self-exercise, and weekly monitoring and feedback through videoconferencing. The exercise program will be tailored and progressively adjusted according to each participant's functional status and clinical progress.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Exercise Adherence Rate
Periodo de tiempo: Baseline through Week 12
Exercise adherence rate will be calculated as the percentage of prescribed exercise sessions completed by each participant during the 12-week remote exercise intervention.
Baseline through Week 12
Exercise Completion Rate
Periodo de tiempo: At Week 12
Exercise completion rate will be calculated as the percentage of participants who complete the 12-week remote exercise intervention as specified in the study protocol.
At Week 12
Participant Satisfaction Score
Periodo de tiempo: Pre-intervention and at Months 1, 2, 3, and 4
Participant satisfaction with the remote exercise intervention will be assessed using a study-specific satisfaction questionnaire at pre-intervention and at Months 1, 2, 3, and 4. Total scores range from 6 to 30, with higher scores indicating greater satisfaction.
Pre-intervention and at Months 1, 2, 3, and 4
Intervention-Related Adverse Events
Periodo de tiempo: Baseline through Month 4
The number of intervention-related adverse events occurring during the study period will be recorded.
Baseline through Month 4
Exercise Intervention Discontinuation
Periodo de tiempo: Baseline through Week 12
The number of participants who discontinue the remote exercise intervention will be recorded. Reasons for discontinuation will also be documented.
Baseline through Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Muscle Thickness by Ultrasound
Periodo de tiempo: Baseline through 12 weeks
Muscle thickness and muscle quality will be assessed using ultrasound to evaluate changes in skeletal muscle following the intervention.
Baseline through 12 weeks
Medical Research Council Sum Score (MRC-SS)
Periodo de tiempo: Baseline through Week 12
Muscle strength will be assessed using the Medical Research Council Sum Score (MRC-SS). Total scores range from 0 to 60, with higher scores indicating greater muscle strength.
Baseline through Week 12
Hand Grip Strength
Periodo de tiempo: Baseline through 12 weeks
Hand grip strength will be measured using a hand dynamometer and recorded in kilograms (kg). Higher values indicate greater hand grip strength.
Baseline through 12 weeks
Body Weight
Periodo de tiempo: Baseline through 12 weeks
Body weight will be measured using a digital scale and recorded in kilograms (kg) to monitor physical changes during the intervention.
Baseline through 12 weeks
Sit and Reach Test
Periodo de tiempo: Baseline through 12 weeks
Flexibility will be assessed using the Sit and Reach Test.
Baseline through 12 weeks
Maximal Inspiratory Pressure (MIP)
Periodo de tiempo: Baseline through Week 12
Inspiratory muscle strength will be assessed using maximal inspiratory pressure (MIP), measured in centimeters of water pressure (cmH₂O). Higher values indicate greater inspiratory muscle strength.
Baseline through Week 12
Maximal Expiratory Pressure (MEP)
Periodo de tiempo: Baseline through Week 12
Expiratory muscle strength will be assessed using maximal expiratory pressure (MEP), measured in centimeters of water pressure (cmH₂O). Higher values indicate greater expiratory muscle strength.
Baseline through Week 12
Peak Cough Flow (PCF)
Periodo de tiempo: Baseline through Week 12
Cough effectiveness will be assessed using peak cough flow (PCF), measured in liters per minute (L/min). Higher values indicate better cough function.
Baseline through Week 12
Pediatric Balance Scale
Periodo de tiempo: Baseline through Week 12
Balance function will be assessed using the Pediatric Balance Scale. Total scores range from 0 to 56, with higher scores indicating better balance function.
Baseline through Week 12
10 Meter Walk Test
Periodo de tiempo: Baseline through 12 weeks
Walking ability will be assessed using the 10 Meter Walk Test. Walking speed will be recorded in meters per second (m/s). Higher values indicate faster walking speed.
Baseline through 12 weeks
Movement Assessment Battery for Children-3 (MABC-3)
Periodo de tiempo: Baseline through Week 12
Motor performance will be assessed using the Movement Assessment Battery for Children-3 (MABC-3). Total standard scores range from 1 to 19, with higher scores indicating better motor performance.
Baseline through Week 12
Physical Activity
Periodo de tiempo: Baseline through Week 16
Physical activity will be continuously monitored using a smartwatch and quantified as metabolic equivalents (METs). Higher MET values indicate greater physical activity levels.
Baseline through Week 16
Modified Barthel Index
Periodo de tiempo: Baseline through 16 weeks
Functional independence in activities of daily living will be assessed using the Modified Barthel Index. Total scores range from 0 to 100, with higher scores indicating greater functional independence in activities of daily living.
Baseline through 16 weeks
Modified Rankin Scale
Periodo de tiempo: Baseline through 16 weeks
Overall functional disability will be assessed using the Modified Rankin Scale. Total scores range from 0 to 6, with higher scores indicating greater functional disability.
Baseline through 16 weeks
Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales
Periodo de tiempo: Baseline through 16 weeks
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scales. Total scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Baseline through 16 weeks
PROMIS Parent Proxy Anxiety
Periodo de tiempo: Baseline through 16 weeks
Anxiety symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Anxiety (Short Form 8a v2.0). Raw summed scores range from 8 to 40 and are converted to standardized T-scores for analysis. Higher T-scores indicate greater anxiety symptoms.
Baseline through 16 weeks
PROMIS Parent Proxy Depressive Symptoms
Periodo de tiempo: Baseline through 16 weeks
Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms (Short Form 6a v2.0). Raw summed scores range from 6 to 30 and are converted to standardized T-scores for analysis. Higher T-scores indicate greater depressive symptoms.
Baseline through 16 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Seoul National University Hospital

Investigadores

  • Investigador principal: Sung Eun Hyun, M.D., Ph.D., Seoul National University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

23 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2026

Publicado por primera vez (Actual)

3 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • H-2606-206-1764

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data are not planned to be shared.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir